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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-four new guidance documents were posted to the tracker since its last update.

 

 

 

 

 

Forty-four new guidance documents on medical devices and diagnostics issued by regulatory authorities from around the world were added to Medtech Insight's Guidance Tracker in the last two months (from Oct. 12 to Nov. 30).

 

 

The US FDA issued 12 guidelines since the last update, including a final document explaining when to submit a 510(k) for a software change to an existing device. While the guideline is helpful, an industry expert believes it does not do enough to address the bigger issue of allowing FDA more discretion to let software medical device-makers update their products quickly without burdensome agency oversight. (Also see "Despite 510(k) Software Guidance, US FDA's Hands May Still Be Tied" - Medtech Insight, 17 Nov, 2017.)

 

 

The updated list also includes a draft guideline from the Saudi Food and Drug Authority outlining the procedure that local manufacturers and authorized representatives should follow to address field safety notices (FSNs) issued in relation to their devices.

 

 

The updated list of new guidance documents is below. The full Medtech Guidance Tracker is online.

 

 

Medtech Guidance Tracker: October-November 2017

 

Key:

WHO: World Health Organization

HC: Health Canada

EMA: European Medicines Agency

NBOG: Notified Body Operations Group

HPRA: Health Products Regulatory Authority

MDA: Medical Device Authority

FDA Philippines: Food and Drug Administration Philippines

Saudi FDA: Saudi Food & Drug Authority

HSA: Health Sciences Authority

MCC: Medicines Control Council

Swissmedic: Swiss Agency for Therapeutic Products

MHRA: Medicines and Healthcare products Regulatory Agency

FDA: Food and Drug Administration

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